Senior Clinical Research Associate

Alexion•Tampa, FL

About The Position

The Senior Clinical Research Associate (Sr. CRA) has local responsibility for delivering studies at allocated sites and participates in local study teams. Working closely with Project Management Clinical Operations, Study Start-Up, Clinical Study Assistants, and other CRAs in Country Operations Management, the Sr. CRA helps ensure study commitments are met efficiently and on time at the country level. The Sr. CRA is the main contact for study sites and monitors study conduct to ensure proper delivery and compliance. The role includes selecting, initiating, monitoring, and closing assigned sites in compliance with Alexion Procedural Documents, ICH-GCP, and applicable local regulations. A Sr. CRA with demonstrated skills and experience may take on additional responsibilities, such as Lead CRA duties. In some countries, the role may also include study start-up and regulatory maintenance tasks.

Requirements

At least 4 years of CRA monitoring experience.
Bachelor’s degree in a related discipline, preferably life science, or equivalent qualification.
Excellent knowledge of ICH-GCP and basic knowledge of GMP/GDP.
Excellent knowledge of relevant local regulations.
Good medical knowledge and ability to learn relevant Alexion therapeutic areas.
Good understanding of the drug development process.
Excellent understanding of clinical study management, including monitoring, study drug handling, and data management.
Excellent attention to detail.
Excellent written and verbal communication skills.
Excellent collaboration and interpersonal skills.
Good negotiation skills.
Flexibility in schedule and willingness to travel; required travel may be as high as 70% during busy periods.
Valid driving license.

Nice To Haves

Ability to work with remote collaborators and in a matrix reporting structure.
Positive approach to change and ability to see change as an opportunity to improve performance and add business value.
Ability to identify and champion more efficient and effective ways to deliver quality clinical trials with reduced budgets and timelines.
Ability to prioritize and manage multiple tasks with conflicting deadlines.
Proactive and assertive communication with internal stakeholders and sites.
Ability to understand technology’s impact on projects and use and develop computer skills in an e-enabled environment.
Team-oriented and flexible, with the ability to respond quickly to changing demands and opportunities.
Experience across all study phases and in rare medical conditions.

Responsibilities

Perform site selection, initiation, interim monitoring, and closeout visits, remotely and onsite, and conduct remote data checks according to the study-specific Clinical Monitoring Plan timelines.
Drive site performance and proactively identify, resolve, and escalate study-related issues as appropriate.
Train, support, and advise investigators and site staff on study matters, including Risk Based Quality Management principles.
Develop recruitment plans with each site and manage and support enrollment to meet study and site milestones; document recruitment barriers and mitigation plans.
Monitor agreed quality KPIs, including action-item aging, SDV metrics, data-entry metrics, query aging, and monitoring-visit report metrics.
Prepare and finalize monitoring visit reports in CTMS and provide timely feedback and follow-up letters to Principal Investigators in accordance with required timelines and Alexion SOPs.
Ensure timely collection and uploading of essential documents to the eTMF in accordance with ICH-GCP, Alexion SOPs, and local requirements.
Support or participate in regular eTMF quality-control checks.
Where required, collect, prepare, review, and track documents and submit applications to EC/IRB and Regulatory Authorities for study start-up and ongoing regulatory maintenance.
Contribute to nomination and selection of potential investigators and assist with feasibility activities.
Collaborate with local Medical Affairs, Medical Advisor Pipeline, and other internal stakeholders as needed.
Escalate systematic or serious quality issues, data privacy breaches, and ICH-GCP compliance issues to the appropriate clinical operations, country management, and quality stakeholders.
Prepare for and collaborate on audits and regulatory inspections with relevant clinical operations and quality stakeholders.